FDA Approvals Bring Investment Opportunities: Alandra Medical

Q: In 2021, you mentioned that investors were cautious about medical technologies, particularly those with long-term returns. Has the investment climate changed since then?

A: The investment climate remains cautious, particularly considering ongoing global and political uncertainties. Nevertheless, at Alandra Medical, we have achieved critical milestones that have enabled us to secure new funding rounds. A pivotal moment was our recent FDA clearance, which granted us authorization to commercialize our technology in the United States. This milestone enhanced our visibility and is attracting more sophisticated investors who understand the complexity and long-term value of medical device innovation. Although structural challenges persist for early-stage companies like ours, demonstrated progress continues to unlock access to strategic capital.

Q: In our previous interview, you mentioned conducting clinical trials with the National Institute of Cardiology. What have been the main clinical and commercial milestones achieved since those trials?

A: Our clinical trials were primarily designed to generate the evidence necessary for regulatory approval. Initially, we focused on the UK, but due to Brexit and other regulatory shifts and delays in Europe, we pivoted to the FDA as a more viable and predictable pathway to meet our development timelines.

The clinical data we obtained through the National Institute of Cardiology in Mexico proved instrumental in supporting our FDA submission, which was ultimately successful. The discipline, scientific rigor, resilience, and curiosity demonstrated in Mexico were key factors in achieving regulatory clearance, with the FDA raising minimal objections during review. This experience underscored the strength of Mexico’s healthcare ecosystem, something too often overlooked in favor of international benchmarks.

Q: How has Alandra Medical’s technology evolved since 2021, particularly in terms of its regulatory strategy and clinical development?

A: Since 2021, our core mission has remained consistent: enabling physicians to detect complications early, thus allowing timely intervention and preventing patient deterioration. While the fundamental design of our technology is straightforward, our strategic evolution lies in how we manage regulatory claims and navigate the approval process without losing alignment with our commercial and scientific ambitions.

In the United States, our approach involves positioning our technology as conventional and low-risk, a critical strategy when seeking clearance under the principle of “substantial equivalence.” This allows us to align our solutions with existing technologies in terms of risk profile and efficacy. As we gather additional clinical evidence, we will continue to refine and expand our claims, maintaining compliance while highlighting differentiated value.

Q: How do you evaluate the current regulatory landscape, particularly considering recent shifts within the US political climate and their potential impact on the FDA?

A: The regulatory framework is designed to prioritize patient safety, and compliance with these standards is non-negotiable. However, there is interpretive space within the guidelines, and successful navigation requires deep understanding and strategic alignment.

Recent political changes in the United States, especially within the FDA, could influence how regulations are applied. Although there are no immediate changes to existing rules, the regulatory tone may shift, affecting review timelines and interpretations.

A more innovation-friendly FDA could accelerate the approval of advanced technologies. However, this also increases the risk of market entry for insufficiently validated products, which could pose long-term risks to patient safety. Given the interconnected nature of global health systems, any regulatory evolution in the United States will likely affect the stance of COFEPRIS and other agencies. We are closely monitoring these developments.

Q: What do you foresee as the potential long-term effects of these regulatory shifts on the healthcare technology sector, particularly regarding the balance between innovation and patient safety?

A: The shifting regulatory landscape introduces both opportunity and risk. A more favorable stance toward innovation could shorten the path to market for emerging technologies, providing a distinct advantage to companies with validated value propositions. However, this must be balanced carefully to avoid the approval of under-evaluated devices that could undermine trust and endanger patients, especially with the increasing usage of AI in healthcare.

The long-term challenge is maintaining rigorous safety and efficacy standards while fostering an environment that supports technological advancement. Achieving this balance is essential for sustainable growth in the sector.

Q: How does Alandra navigate such shifts, especially when dealing with suppliers and potential buyers in a rapidly changing environment?

A: The current environment is characterized by volatility, which we interpret as a transitional phase. Unlike companies directly selling to hospitals, our business model is based on intellectual property, in a way that our clients are large-scale corporations who serve as the ultimate manufacturers and distributors of our technology.

Our primary challenge is to maintain a resilient supply chain with validated partners and to present a compelling value narrative to these larger players. Tariff changes and currency fluctuations do impact on our models, but our business is structured to remain relatively insulated from immediate shocks. That said, we are not complacent. We actively monitor the macroeconomic landscape to ensure we can adapt quickly to evolving conditions, both operationally and strategically.

Q: Could you give us an example of how you have had to navigate regulations or adjust your approach to bring a product to market?

A: One example involves our strategic positioning of technologies like Florence and Athena under the concept of “substantial equivalence.” We identified a predicate device used to measure electrical changes in the esophagus related to gastric reflux, a device with similar technological principles to ours.

Although our application focuses on the stomach, we demonstrated that the technical foundation and risk profile were comparable. This required robust scientific argumentation, the involvement of clinical experts, and the guidance of regulatory consultants. We presented a compelling, evidence-based case to the FDA, showing that our innovation posed no greater risk than existing approved devices. In essence, we strategically navigated the regulations by aligning our novel technology with proven analogs, always adhering to ethical and safety standards.

Q: What are Alandra Medical’s key strategic objectives and main goals for the end of 2025?

A: Our primary objective for 2025 is to secure reimbursement codes in the United States. This is critical for long-term commercial viability and involves close collaboration with insurance providers to validate the clinical and economic value of our technology.

Additionally, we are expanding our patent portfolio to protect the innovations that we are incorporating into the next generation of the Mucosal Impedance Measurement System. By year-end, we aim to complete these filings and secure at least one letter of intent or a formal agreement for technology transfer. Both are key milestones that will support our financial and strategic objectives.

Alandra Medical has the mission of transforming critical care with continuous, low-risk monitoring that improves outcomes and eases caregiver burden.